Disposable article having a biosensor

ABSTRACT

A disposable article to be fitted to a wearer comprising a biosensor including at least one bio-recognition element. The biosensor is adapted to detect a target biological analyte in bodily waste or on the wearer&#39;s skin.

CROSS REFERENCE TO RELATED APPLICATIONS

[0001] This application is a continuation of U.S. application Ser. No.09/299,399, filed Apr. 26, 1999.

FIELD OF THE INVENTION

[0002] The present invention relates to disposable articles and, moreparticularly, to disposable articles having biosensors having abio-recognition element that detects microorganisms and/or otherbiomolecules in bodily waste.

BACKGROUND OF THE INVENTION

[0003] Today, disposable articles, such as diapers, adult incontinencebriefs, sanitary napkins and tampons, are widely used in infant andtoddler care and in the care of incontinent adults as a means ofcontaining, isolating and disposing of bodily wastes. These articleshave generally replaced reusable, washable cloth garments as thepreferred means for these applications because of their convenience andreliability. The disposable articles respond to a defecation, urinationor discharge event by absorbing or containing bodily wastes deposited onthe article. Some disposable articles also signal a defecation,urination or discharge event after it has occurred (e.g., wetnessindicators, temperature change detection). Other disposable absorbentarticles known in the art comprise a chemically reactive means to detectvarious substances in the wearer's waste(s). However, none of thesespecifically detect target potentially pathogenic microorganisms such asbacteria, viruses, fungi, and parasites (e.g., protozoans) and/orrelated biomolecules, all of which require a high degree of selectivity(i.e., specificity) and sensitivity versus purely chemical agents.Additionally, the articles do not predict when a health-related event isabout to occur and signal wearer or caregiver that prophylactic orremedial action is required prior to the onset of clinically observablesymptoms.

SUMMARY OF THE INVENTION

[0004] The present invention is directed to a disposable article to befitted to a wearer comprising a biosensor including at least onebio-recognition element. The biosensor is adapted to detect a targetbiological analyte in bodily waste or on the wearer's skin. Morepreferably, the absorbent article of the present invention may comprisea biosensor adapted to detect one or more specific microorganisms and/orrelated biomolecules and to signal the caretaker, the wearer, or anactuator of the occurrence.

BRIEF DESCRIPTION OF THE DRAWINGS

[0005]FIG. 1 is a plan view of the article made in accordance with thepresent invention in a flat-out state with portions of the structurebeing cut-away to more clearly show the construction of the article,wherein the article is a diaper.

[0006]FIG. 2 shows a perspective view of a bodily waste isolation deviceof the present invention in a compressed state before activation.

[0007]FIG. 2A shows a sectional view taken along line 2A-2A of FIG. 2.

[0008]FIG. 3A shows an ideal output function of a discontinuousresponsive system of the present invention having a single thresholdlevel.

[0009]FIG. 3B shows an ideal output function of a discontinuousresponsive system of the present invention having multiple thresholdlevels.

[0010]FIG. 4A shows an exemplary output function of a discontinuousresponsive system of the present invention along with the first, secondand third derivatives of the output function.

[0011]FIG. 4B shows a transfer function of a control system having aseries of first order lags having an equal time constant.

[0012]FIGS. 5A and 5B show an embodiment of a responsive system of thepresent invention including an electrically sensitive gel.

[0013]FIGS. 6A, 6B and 6C show another embodiment of a responsive systemof the present invention including an electrically sensitive gel.

[0014]FIG. 7 is a perspective view of a waste bag embodiment of thepresent invention.

[0015]FIG. 8 is a perspective view of an absorbent article including awaste bag.

DETAILED DESCRIPTION OF THE INVENTION

[0016] As used herein, the term “absorbent article” refers to deviceswhich absorb and contain body exudates, and more specifically, refers todevices which are placed against or in proximity to the body of thewearer to absorb and contain the various exudates discharged from thebody. The term “disposable” is used herein to describe absorbentarticles which generally are not intended to be laundered or otherwiserestored or reused as an absorbent article (i.e., they are intended tobe discarded after a single use and, preferably, to be recycled,composted or otherwise disposed of in an environmentally compatiblemanner). (As used herein, the term “disposed” is used to mean that anelement(s) of the diaper is formed (joined and positioned) in aparticular place or position as a unitary structure with other elementsof the diaper or as a separate element joined to another element of thediaper. As used herein, the term “joined” encompasses configurationswhereby an element is directly secured to another element by affixingthe element directly to the other element, and configurations whereby anelement is indirectly secured to another element by affixing the elementto intermediate member(s) which in turn are affixed to the otherelement.) A “unitary” absorbent article refers to absorbent articleswhich are formed of separate parts united together to form a coordinatedentity so that they do not require separate manipulative parts like aseparate holder and liner. A preferred embodiment of an absorbentarticle of the present invention is a unitary disposable absorbentarticle, such as the diaper 20 shown in FIG. 1. As used herein, the term“diaper” refers to an absorbent article generally worn by infants andincontinent persons about the lower torso. The present invention is alsoapplicable to other absorbent or non-absorbent articles such asincontinence briefs, incontinence undergarments, absorbent inserts,diaper holders and liners, colostomy bags for a natural or artificialanus, feminine hygiene garments, tampons, wipes, disposable towels,tissues, water absorbing articles, oil absorbing articles, spill cleanupbags, desiccant bags, disposable mops, bandages, therapeutic wraps,supports, disposable heating pads and the like.

[0017]FIG. 1 is a plan view of the diaper 20 of the present invention ina flat-out, state with portions of the structure being cut-away to moreclearly show the construction of the diaper 20. The portion of thediaper 20 which faces the wearer is oriented towards the viewer. Asshown in FIG. 1, the diaper 20 preferably comprises a liquid pervioustopsheet 24; a liquid impervious backsheet 26; an absorbent core 28,which is preferably positioned between at least a portion of thetopsheet 24 and the backsheet 26; side panels 30; elasticized leg cuffs32; an elastic waist feature 34; and a fastening system generallydesignated 40. Diaper 20 is shown in FIG. 1 to have a first waist region36, a second waist region 38 opposed to the first waist region 36 and acrotch region 37 located between the first waist region and the secondwaist region. The periphery of the diaper 20 is defined by the outeredges of the diaper 20 in which the longitudinal edges 50 run generallyparallel to the longitudinal centerline 100 of the diaper 20 and the endedges 52 run between the longitudinal edges 50 generally parallel to thelateral centerline 110 of the diaper 20.

[0018] The chassis 22 of the diaper 20 comprises the main body of thediaper 20. The chassis 22 comprises at least a portion of the absorbentcore 28 and preferably an outer covering layer including the topsheet 24and the backsheet 26. If the absorbent article comprises a separateholder and a liner, the chassis 22 generally comprises the holder andthe liner. (For example, the holder may comprise one or more layers ofmaterial to form the outer cover of the article and the liner maycomprise an absorbent assembly including a topsheet, a backsheet, and anabsorbent core. In such cases, the holder and/or the liner may include afastening element which is used to hold the liner in place throughoutthe time of use.) For unitary absorbent articles, the chassis 22comprises the main structure of the diaper with other features added toform the composite diaper structure. While the topsheet 24, thebacksheet 26, and the absorbent core 26 may be assembled in a variety ofwell known configurations, preferred diaper configurations are describedgenerally in U.S. Pat. No. 3,860,003 entitled “Contractible SidePortions for Disposable Diaper” which issued to Kenneth B. Buell on Jan.14, 1975; U.S. Pat. No. 5,151,092 issued to Buell on Sep. 9, 1992; andU.S. Pat. No. 5,221,274 issued to Buell on Jun. 22, 1993; and U.S. Pat.No. 5,554,145 entitled “Absorbent Article With Multiple Zone StructuralElastic-Like Film Web Extensible Waist Feature” which issued to Roe etal. on Sep. 10, 1996; U.S. Pat. No. 5,569,234 entitled “DisposablePull-On Pant” which issued to Buell et al. on Oct. 29, 1996; U.S. Pat.No. 5,580,411 entitled “Zero Scrap Method For Manufacturing Side PanelsFor Absorbent Articles” which issued to Nease et al. on Dec. 3, 1996;and U.S. patent application Ser. No. 08/915,471 entitled “AbsorbentArticle With Multi-Directional Extensible Side Panels” filed Aug. 20,1997 in the name of Robles et al.; each of which is incorporated hereinby reference.

[0019] The backsheet 26 is generally that portion of the diaper 20positioned adjacent the garment facing surface 45 of the absorbent core28 which prevents the exudates absorbed and contained therein fromsoiling articles which may contact the diaper 20, such as bedsheets andundergarments. The backsheet 26 may be joined to the topsheet 24, theabsorbent core 28 or any other element of the diaper 20 by anyattachment means known in the art. Suitable backsheet films includethose manufactured by Tredegar Industries Inc. of Terre Haute, Ind. andsold under the trade names X15306, X10962 and X10964. Other suitablebacksheet materials may include breathable materials such as woven webs,nonwoven webs, composite materials such as film-coated nonwoven webs,and microporous films such as manufactured by Mitsui Toatsu Co., ofJapan under the designation ESPOIR NO; EXXON Chemical Co., of Bay City,Tex., under the designation EXXAIRE; or monolithic films such asmanufactured by Clopay Corporation, Cincinnati, Ohio under the nameHYTREL blend P18-3097. Such breathable composite materials are describedin greater detail in PCT Application No. WO 95/16746, published on Jun.22, 1995 in the name of E. I. DuPont; copending U.S. Pat. No. 5,865,823issued to Curro on Feb. 2, 1999; U.S. Pat. No. 5,571,096 issued toDobrin et al. on Nov. 5, 1996. Each of these references is herebyincorporated by reference herein.

[0020] The backsheet 26, or any portion thereof, may be elasticallyextensible in one or more directions. In one embodiment, the backsheet26 may comprise a structural elastic-like film (“SELF”) web. Astructural elastic-like film web is an extensible material that exhibitsan elastic-like behavior in the direction of elongation without the useof added elastic materials. SELF webs suitable for the present inventionare described in U.S. Pat. No. 5,518,801 entitled Web MaterialsExhibiting Elastic-Like Behavior, which issued to Chappell, et, al. onMay 21, 1996, which is incorporated herein by reference. In alternateembodiments, the backsheet 26 may comprise elastomeric films, foams,strands, or combinations of these or other suitable materials withnonwovens or synthetic films.

[0021] The topsheet 24 is preferably compliant, soft feeling, andnon-irritating to the wearer's skin. A suitable topsheet 24 may bemanufactured from a wide range of materials, such as porous foams;reticulated foams; apertured plastic films; or woven or nonwoven webs ofnatural fibers (e.g., wood or cotton fibers), synthetic fibers (e.g.,polyester or polypropylene fibers), or a combination of natural andsynthetic fibers. If the topsheets include fibers, the fibers may bespunbond, carded, wet-laid, meltblown, hydroentangled, or otherwiseprocessed as is known in the art. One suitable topsheet 24 comprising aweb of staple length polypropylene fibers is manufactured by Veratec,Inc., a Division of International Paper Company, of Walpole,Massachusetts under the designation P-8.

[0022] Suitable formed film topsheets are described in U.S. Pat. No.3,929,135, entitled “Absorptive Structures Having Tapered Capillaries”,which issued to Thompson on Dec. 30, 1975; U.S. Pat. No. 4,324,246entitled “Disposable Absorbent Article Having A Stain ResistantTopsheet”, which issued to Mullane, et al. on Apr. 13, 1982; U.S. Pat.No. 4,342,314 entitled “Resilient Plastic Web Exhibiting Fiber-LikeProperties”, which issued to Radel, et al. on Aug. 3, 1982; U.S. Pat.No. 4,463,045 entitled “Macroscopically Expanded Three-DimensionalPlastic Web Exhibiting Non-Glossy Visible Surface and Cloth-Like TactileImpression”, which issued to Ahr, et al. on Jul. 31, 1984; and U.S. Pat.No. 5,006,394 “Multilayer Polymeric Film” issued to Baird on Apr. 9,1991. Other suitable topsheets 30 are made in accordance with U.S. Pat.Nos. 4,609,518 and 4,629,643 which issued to Curro et al. on Sep. 2,1986 and Dec. 16, 1986, respectively, and both of which are incorporatedherein by reference. Such formed films are available from The Procter &Gamble Company of Cincinnati, Ohio as “DRI-WEAVE” and from TredegarCorporation of Terre Haute, Indiana as “CLIFF-T.”

[0023] Preferably, the topsheet 24 is made of a hydrophobic material oris treated to be hydrophobic in order to isolate the wearer's skin fromliquids contained in the absorbent core 28. If the topsheet 24 is madeof a hydrophobic material, preferably at least the upper surface of thetopsheet 24 is treated to be hydrophilic so that liquids will transferthrough the topsheet more rapidly. The topsheet 24 can be renderedhydrophilic by treating it with a surfactant or by incorporating asurfactant into the topsheet. Suitable methods for treating the topsheet24 with a surfactant include spraying the topsheet 24 material with thesurfactant and immersing the material into the surfactant. A moredetailed discussion of such a treatment and hydrophilicity is containedin U.S. Pat. No. 4,988,344 entitled “Absorbent Articles with MultipleLayer Absorbent Layers” issued to Reising, et al. on Jan. 29, 1991 andU.S. Pat. No. 4,988,345 entitled “Absorbent Articles with RapidAcquiring Absorbent Cores” issued to Reising on Jan. 29, 1991. A moredetailed discussion of some suitable methods for incorporatingsurfactant in the topsheet can be found in U.S. Statutory InventionRegistration No. H1670, published on Jul. 1, 1997 in the names of Azizet al. Each of these references is hereby incorporated by referenceherein.

[0024] Any portion of the topsheet 24 or other components of the articlemay be coated with a lotion as is known in the art. Examples of suitablelotions include those described in U.S. Pat. No. 5,607,760 entitled“Disposable Absorbent Article Having A Lotioned Topsheet Containing anEmollient and a Polyol Polyester Imobilizing Agent” which issued to Roeon Mar. 4, 1997; U.S. Pat. No. 5,609,587 entitled “Diaper Having ALotion Topsheet Comprising A Liquid Polyol Polyester Emollient And AnImmobilizing Agent” which issued to Roe on Mar. 11, 1997; U.S. Pat. No.5,635,191 entitled “Diaper Having A Lotioned Topsheet Containing APolysiloxane Emollient” which issued to Roe et al. on Jun. 3, 1997; andU.S. Pat. No. 5,643,588 entitled “Diaper Having A Lotioned Topsheet”which issued to Roe et al. on Jul. 1, 1997. The lotion may functionalone or in combination with another agent as the hydrophobizingtreatment described above. The topsheet may also include or be treatedwith antibacterial agents, some examples of which are disclosed in PCTPublication No. WO 95/24173 entitled “Absorbent Articles ContainingAntibacterial Agents in the Topsheet For Odor Control” which waspublished on Sep. 14, 1995 in the name of Theresa Johnson. Further, thetopsheet 24, the backsheet 26 or any portion of the topsheet orbacksheet may be embossed and/or matte finished to provide a more clothlike appearance.

[0025] The absorbent core 28 may comprise any absorbent material whichis generally compressible, conformable, non-irritating to the wearer'sskin, and capable of absorbing and retaining liquids such as urine andother certain body exudates. The absorbent core 28 may be manufacturedin a wide variety of sizes and shapes (e.g., rectangular, hourglass,“T”-shaped, asymmetric, etc.) and may comprise a wide variety ofliquid-absorbent materials commonly used in disposable diapers and otherabsorbent articles such as comminuted wood pulp, which is generallyreferred to as airfelt. Examples of other suitable absorbent materialsinclude creped cellulose wadding; meltblown polymers, including coform;chemically stiffened, modified or cross-linked cellulosic fibers;tissue, including tissue wraps and tissue laminates; absorbent foams;absorbent sponges; superabsorbent polymers; absorbent gelling materials;or any other known absorbent material or combinations of materials.

[0026] The configuration and construction of the absorbent core 28 mayalso be varied (e.g., the absorbent core(s) or other absorbentstructure(s) may have varying caliper zones, a hydrophilic gradient, asuperabsorbent gradient, or lower average density and lower averagebasis weight acquisition zones; or may comprise one or more layers orstructures).

[0027] Exemplary absorbent structures for use as the absorbentassemblies are described in U.S. Pat. No. 4,610,678 entitled“High-Density Absorbent Structures” issued to Weisman et al. on Sep. 9,1986; U.S. Pat. No. 4,673,402 entitled “Absorbent Articles WithDual-Layered Cores” issued to Weisman et al. on Jun. 16, 1987; U.S. Pat.No. 4,834,735, entitled “High Density Absorbent Members Having LowerDensity and Lower Basis Weight Acquisition Zones”, issued to Alemany etal. on May 30, 1989; U.S. Pat. No. 4,888,231 entitled “Absorbent CoreHaving A Dusting Layer” issued to Angstadt on Dec. 19, 1989; U.S. Pat.No. 5,137,537 entitled “Absorbent Structure Containing Individualized,Polycarboxylic Acid Crosslinked Wood Pulp Cellulose Fibers” which issuedto Herron et al. on Aug. 11, 1992; U.S. Pat. No. 5,147,345 entitled“High Efficiency Absorbent Articles For Incontinence Management” issuedto Young et al. on Sep. 15, 1992; U.S. Pat. No. 5,342,338 entitled“Disposable Absorbent Article For Low-Viscosity Fecal Material” issuedto Roe on Aug. 30, 1994; U.S. Pat. No. 5,260,345 entitled “AbsorbentFoam Materials For Aqueous Body Fluids and Absorbent Articles ContainingSuch Materials” issued to DesMarais et al. on Nov. 9, 1993; U.S. Pat.No. 5,387,207 entitled “Thin-Until-Wet Absorbent Foam Materials ForAqueous Body Fluids And Process For Making Same” issued to Dyer et al.on Feb. 7, 1995; and U.S. Pat. No. 5,625,222 entitled “Absorbent FoamMaterials For Aqueous Fluids Made From high Internal Phase EmulsionsHaving Very High Water-To-Oil Ratios” issued to DesMarais et al. on Jul.22, 1997. Each of these patents is incorporated herein by reference.

[0028] The diaper 20 may also comprise at least one elastic waistfeature 34 that helps to provide improved fit and containment. Theelastic waist feature 34 preferably extends at least longitudinallyoutwardly from at least one waist edge 62 of the absorbent core 28 andgenerally forms at least a portion of the end edge 52 of the diaper 20.Disposable diapers are often constructed so as to have two elastic waistfeatures, one positioned in the first waist region 36 and one positionedin the second waist region 38. Further, while the elastic waist feature34 or any of its constituent elements may comprise one or more separateelements affixed to the diaper 20, the elastic waist feature 34 may beconstructed as an extension of other elements of the diaper 20, such asthe backsheet 26, the topsheet 24, or both the backsheet 26 and thetopsheet 24.

[0029] The elastic waist feature 34 may be constructed in a number ofdifferent configurations including those described in U.S. Pat. No.4,515,595 issued to Kievit et al. on May 7, 1985; U.S. Pat. No.4,710,189 issued to Lash on Dec. 1, 1987; U.S. Pat. No. 5,151,092 issuedto Buell on Sep. 9, 1992; and U.S. Pat. No. 5,221,274 issued to Buell onJun. 22, 1993. Other suitable waist configurations may include waistcapfeatures such as those described in U.S. Pat. No. 5,026,364 issued toRobertson on Jun. 25, 1991 and U.S. Pat. No. 4,816,025 issued to Foremanon Mar. 28, 1989. All of the above mentioned references are incorporatedherein by reference.

[0030] The diaper 20 may also include a fastening system 40. Thefastening system 40 preferably comprises tape tabs and/or hook and loopfastening components, although any other known fastening means aregenerally acceptable. Some exemplary fastening systems are disclosed inU.S. Pat. No. 3,848,594 entitled “Tape Fastening System for DisposableDiaper” issued to Buell on Nov. 19, 1974; U.S. Pat. No. 4,662,875entitled “Absorbent Article” issued to Hirotsu et al. on May 5, 1987;U.S. Pat. No. 4,846,815 entitled “Disposable Diaper Having An ImprovedFastening Device” issued to Scripps on Jul. 11, 1989; U.S. Pat. No.4,894,060 entitled “Disposable Diaper With Improved Hook FastenerPortion” issued to Nestegard on Jan. 16, 1990; U.S. Pat. No. 4,946,527entitled “Pressure-Sensitive Adhesive Fastener And Method of MakingSame” issued to Battrell on Aug. 7, 1990; and the herein beforereferenced U.S. Pat. No. 5,151,092 issued to Buell on Sep. 9, 1992; andU.S. Pat. No. 5,221,274 issued to Buell on Jun. 22, 1993. The fasteningsystem may also provide a means for holding the article in a disposalconfiguration as disclosed in U.S. Pat. No. 4,963,140 issued toRobertson et al. on Oct. 16, 1990. Each of these patents is incorporatedherein by reference. In alternative embodiments, opposing sides of thegarment may be seamed or welded to form a pant. This allows the articleto be used as a pull-on type diaper, such as a training pant.

[0031] The diaper 20 may also comprise side panels 30. The side panels30 may be elastic or extensible to provide a more comfortable andcontouring fit by initially conformably fitting the diaper 20 to thewearer and sustaining this fit throughout the time of wear well pastwhen the diaper 20 has been loaded with exudates since the elasticizedside panels 30 allow the sides of the diaper 20 to expand and contract.

[0032] While the diaper 20 of the present invention preferably has theside panels 30 disposed in the second waist region 38, the diaper 20 maybe provided with side panels 30 disposed in the first waist region 36 orin both the first waist region 36 and the second waist region 38. Theside panels 30 may be constructed in any suitable configurations.Examples of diapers with elasticized side panels are disclosed in U.S.Pat. No. 4,857,067, entitled “Disposable Diaper Having Shirred Ears”issued to Wood, et al. on Aug. 15, 1989; U.S. Pat. No. 4,381,781 issuedto Sciaraffa, et al. on May 3, 1983; U.S. Pat. No. 4,938,753 issued toVan Gompel, et al. on Jul. 3, 1990; the herein before referenced U.S.Pat. No. 5,151,092 issued to Buell on Sep. 9, 1992; and U.S. Pat. No.5,221,274 issued to Buell on Jun. 22, 1993; U.S. Pat. No. 5,669,897issued to LaVon, et al. on Sep. 23, 1997 entitled “Absorbent ArticlesProviding Sustained Dynamic Fit”; U.S. patent application Ser. No.08/915,471 entitled “Absorbent Article With Multi-Directional ExtensibleSide Panels” filed Aug. 20, 1997 in the names of Robles, et al.; each ofwhich is incorporated herein by reference.

[0033] The diaper 20 preferably further includes leg cuffs 32 whichprovide improved containment of liquids and other body exudates. Legcuffs may also be referred to as leg bands, side flaps, barrier cuffs,or elastic cuffs. U.S. Pat. No. 3,860,003 describes a disposable diaperwhich provides a contractible leg opening having a side flap and one ormore elastic members to provide an elasticized leg cuff (a gasketingcuff). U.S. Pat. Nos. 4,808,178 and 4,909,803 issued to Aziz et al. onFeb. 28, 1989 and Mar. 20, 1990, respectively, describe disposablediapers having “stand-up” elasticized flaps (barrier cuffs) whichimprove the containment of the leg regions. U.S. Pat. Nos. 4,695,278 and4,795,454 issued to Lawson on Sep. 22, 1987 and to Dragoo on Jan. 3,1989, respectively, describe disposable diapers having dual cuffs,including gasketing cuffs and barrier cuffs. In some embodiments, it maybe desirable to treat all or a portion of the leg cuffs with a lotion,as described above.

[0034] Embodiments of the present invention may also include pockets forreceiving and containing waste, spacers which provide voids for waste,barriers for limiting the movement of waste in the article, compartmentsor voids which accept and contain waste materials deposited in thediaper, and the like, or any combinations thereof. Examples of pocketsand spacers for use in absorbent products are described in U.S. Pat. No.5,514,121 issued to Roe et al. on May 7, 1996, entitled “Diaper HavingExpulsive Spacer”; U.S. Pat. No. 5,171,236 issued to Dreier et al onDec. 15, 1992, entitled “Disposable Absorbent Article Having CoreSpacers”; U.S. Pat. No. 5,397,318 issued to Dreier on Mar. 14, 1995,entitled “Absorbent Article Having A Pocket Cuff”; U.S. Pat. No.5,540,671 issued to Dreier on Jul. 30, 1996, entitled “Absorbent ArticleHaving A Pocket Cuff With An Apex”; and PCT Application WO 93/25172published Dec. 3, 1993, entitled “Spacers For Use In Hygienic AbsorbentArticles And Disposable Absorbent Articles Having Such Spacer”; and U.S.Pat. No. 5,306,266, entitled “Flexible Spacers For Use In DisposableAbsorbent Articles”, issued to Freeland on Apr. 26, 1994. Examples ofcompartments or voids are disclosed in U.S. Pat. No. 4,968,312, entitled“Disposable Fecal Compartmenting Diaper”, issued to Khan on Nov. 6,1990; U.S. Pat. No. 4,990,147, entitled “Absorbent Article With ElasticLiner For Waste Material Isolation”, issued to Freeland on Feb. 5, 1991;U.S. Pat. No. 5,62,840, entitled “Disposable Diapers”, issued to Holt etal on Nov. 5, 1991; and U.S. Pat. No. 5,269,755 entitled “TrisectionTopsheets For Disposable Absorbent Articles And Disposable AbsorbentArticles Having Such Trisection Topsheets”, issued to Freeland et al onDec. 14, 1993. Examples of suitable transverse barriers are described inU.S. Pat. No. 5,554,142 entitled “Absorbent Article Having MultipleEffective Height Transverse Partition” issued Sep. 10, 1996 in the nameof Dreier et al.; PCT Patent WO 94/14395 entitled “Absorbent ArticleHaving An Upstanding Transverse Partition” published Jul. 7, 1994 in thename of Freeland, et al.; and U.S. Pat. No. 5,653,703 Absorbent ArticleHaving Angular Upstanding Transverse Partition, issued Aug. 5, 1997 toRoe, et al. All of the above-cited references are hereby incorporated byreference herein.

[0035] Embodiments of the present invention may also include a wastemanagement device 110 such as is shown in FIG. 7. The waste managementdevice 110 may include a waste bag 111 to collect feces, urine or both.The waste bag 111 may have an aperture 121 and a flange 112 surroundingthe aperture for preferably adhesive attachment to the perianal area ofa wearer. Further, the waste management device 110 has been found to beparticularly useful and beneficial when used in conjunction with agarment, or diaper, preferably a disposable diaper. One example of anabsorbent article, such as the diaper 120 including a waste bag 111 isshown in FIG. 8. If associated with a diaper 120 or other garment, thewaste bag 111 may be disposed on or joined to any surface of thearticle. In one embodiment, the waste bag 111 is joined to the topsheet124 of the diaper 120.

[0036] The waste bag 111 is preferably a flexible receptacle for thecontainment of excreted fecal matter or urine. Thus, the waste bag 111is preferably liquid impermeable, and yet it may be breathable. Further,the waste bag 111 is designed of sufficient strength to withstandtypical wearing conditions, such as sitting.

[0037] The waste bag 111 may comprise one or multiple layers. In oneembodiment, the waste bag 111 may comprise three layers, preferably onefilm and two non-woven layers. The layers of the bag material maycomprise any material, preferably so that the bag is liquid impervious.In a preferred embodiment of the present invention a laminate may beformed from a non-woven layer and a film.

[0038] Suitable film materials for any of the film layers preferablycomprise a thermoplastic material. The thermoplastic material can may bevapor pervious or impervious and can be selected from among all types ofhot-melt adhesives, polyolefins especially polyethylene, polypropylene,amorphous polyolefins, and the like; material containing meltablecomponents comprising fibres or polymeric binders including naturalfibres such as cellulose—wood pulp, cotton, jute, hemp; synthetic fibressuch as fibreglass, rayon, polyester, polyolefin, acrylic, polyamid,aramid, polytetrafluroethylene metal, polyimide; binders such asbicomponent high melt/low melt polymer, copolymer polyester, polyvinylchloride, polyvinyl acetate/chloride copolymer, copolymer polyamide,materials comprising blends wherein some of the constituent materialsare not meltable; air and vapour permeable materials includingmicroporous films such as those described above with respect to thebacksheet and monolithic breathable materials such as HYTREL™ availablefrom DuPont and Pebax™ available from ELF Atochem, France.

[0039] The waste bag 111 may have any shape or size. Preferred shapesinclude flat circular type bags, cone shaped bags, truncated cone shapedbags and pyramidal or truncated pyramidal shaped bags and flat T shapedbags. Further, the waste bag 111 may be provided from a unitary piece ofmaterial or a number of separate pieces of material which may beidentical or different and which may be sealed at their respectiveperipheries.

[0040] The waste bag 111 may also contain absorbent material. Theabsorbent material may comprise any absorbent material which is capableof absorbing and retaining liquids. The absorbent material may comprisea wide variety of liquid-absorbent materials commonly used in disposablediapers and other absorbent articles. Some examples are described hereinwith respect to the absorbent core.

[0041] The waste bag 111 is provided with an aperture 121 whereby fecalmatter or urine is received from the body prior to storage within thebag cavity. The aperture 121 is preferably surrounded by a flange 112and may be provided in any shape or size, such as circular, oblong,heart shaped and may be symmetrical or asymmetrical, preferably theaperture has an oblong configuration either in the longitudinal or inthe transversal direction. The flange may comprise projections designedto fit the perineal, genital and/or coccygeal area of the wearer.

[0042] The flange 112 should be made of soft, flexible and malleablematerial to allow easy placement of the flange 112 to the perianal oruro-genital area. Typical materials include nonwoven materials, wovens,open celled thermoplastic foams, closed-cell thermoplastic foams,composites of open celled foams and stretch nonwoven, and films.

[0043] The waste bag 111 preferably further comprises an attachmentmeans to secure the device to the wearer. Such means may comprise strapsand or a body-compatible pressure sensitive adhesive applied to thewearer facing portion of the waste bag 111 or the flange. Anyskin-friendly water resistant pressure sensitive adhesive may be used toattach the device to the perianal or uro-genital area of the wearer,such as hydrocolloid adhesives and hydrogel adhesives. Particularlyeffective adhesives in providing the desired adhesive properties tosecure the flange to the skin of the wearer at the sensitive perianalarea, while allowing for relatively painless application and removal,are formed from crosslinking polymers with a plasticizer to form a3-dimensional matrix.

[0044] The article 20 preferably also includes at least one biosensor60. As used herein, the term “biosensor” is defined as a componentcomprising one or more biologically reactive means being adapted todetect one or more target pathogenic microorganisms or relatedbiomolecules (e.g., an enzyme sensor, organella sensor, tissue sensor,microorganism sensor, immunosensor or electrochemical sensor),additionally having the capability to provide a signal of said detectionto the wearer, caretaker, or an actuator. The term “biologicallyreactive” is defined as having the capability to selectively interactwith, and preferably bind, target pathogenic microorganisms and/orrelated biomolecules as described herein. Generally, biosensors functionby providing a means of specifically binding, and therefore detecting, atarget biologically active analyte. In this way, the biosensor is highlyselective, even when presented with a mixture of many chemical andbiological entities, such as feces. Chemical sensors, on the other hand,which rely on chemically reactive means, generally do not have eitherthe high selectivity or the amplification properties of biosensors and,therefore, are not well suited to detect biologically reactive analytes,especially when they are present in low concentrations and/or in acomplex media such as bodily waste. Often the target biological analyteis a minor component of a complex mixture comprising a multiplicity ofbiological and other components. Thus, in many biosensor applications,detection of target analytes to the parts-per-billion,parts-per-trillion, or even lower levels is necessary. Accordingly,discrimination ratios of about 10⁷-10⁸ or greater may be required forthe biosensor to recognize the target biological analyte in a complexmixture.

[0045] The biosensor of the present invention comprises abio-recognition element, or molecular recognition element, that providesthe highly specific binding or detection selectivity for a particularanalyte. The bio-recognition element, or system, may be a biologicallyderived material such as an enzyme or sequence of enzymes; an antibody;a membrane receptor protein; DNA; an organelle, a natural or syntheticcell membrane; an intact or partial viable or nonviable bacterial, plantor animal cell; or a piece of plant or mammalian tissues, and generallyfunctions to interact specifically with a target biological analyte. Thebio-recognition element is responsible for the selective recognition ofthe analyte and the physico-chemical signal that provides the basis forthe output signal.

[0046] Biosensors may include biocatalytic biosensors, and bioaffinitybiosensors. In biocatalytic biosensor embodiments, the bio-recognitionelement is “biocatalytic” and may comprise an enzyme, organelle, pieceof plant or mammalian tissue, or whole cells, the selective bindingsites “turn over” (i.e., can be used again during the detectionprocess), resulting in a significant amplification of the input signal.Biocatalytic sensors such as these are generally useful for real-time,continuous sensing.

[0047] Bioaffinity sensors are generally applicable to bacteria,viruses, and toxins and include chemoreceptor-based biosensors and/orimmunological sensors (i.e. immunosensors). Chemoreceptors are complexbiomolecular macroassemblies responsible, in part, for a viableorganism's ability to sense chemicals in its environment with highselectivity. Chemoreceptor-based biosensors comprise one or more naturalor synthetic chemoreceptors associated with a means to provide a signal(visual, electrical, etc.) of the presence or concentration of a targetbiological analyte. In certain embodiments, the chemoreceptor may beassociated with an electrode (i.e., an electrical transducer) so as toprovide a detectable electrical signal. Chemoreceptors may include wholeor partial nerve bundles (e.g., from antennae or other sensing organs)and/or whole or partial natural or synthetic cell membranes. On theother hand, the bio-recognition elements of immunosensors are generallyantibodies. Antibodies are highly specific and can be made towardbacteria, viruses, fragments of microorganisms (e.g., bacterial cellwalls, parasite eggs or portions thereof, etc.), and large biomolecules.Suitable antibodies may be monoclonal or polyclonal. In any case,bioaffinity biosensors are generally irreversible because the receptorsites of the biosensor become saturated when exposed to the targetbiological analyte.

[0048] In certain embodiments, biocatalytic bioaffinity biosensors maybe combined, such as RNA/DNA probes or other high-affinity bindingsystems wherein the initial bio-recognition event is followed bybiological amplification of the signal. For example, a specific bacteriamay be detected by a biosensor comprising genetic material, such as DNA,as a bio-recognition element and PCR (i.e., polymerase chain reaction)amplification to detect small numbers of organisms, preferably less thanor equal to about 500. Biocatalytic and bioaffinity biosensor systemsare described in more detail in Journal of Chromatography, 510 (1990)347-354 and in the Kirk-Othmer Encyclopedia of Chemical Technology,4^(th) ed. (1992), John Wiley & Sons, NY, the disclosure of which isincorporated by reference herein.

[0049] The biosensors of the present invention preferably detectbiologically active analytes related to impending (i.e., futurepresentation of symptoms is likely) or current human systemic diseasestates, including, but not limited to, pathogenic bacteria, parasites(e.g., any stage of the life cycle, including eggs or portions thereof,cysts, or mature organisms), viruses, fungi such as Candida albicans,antibodies to pathogens, and/or microbially produced toxins.Additionally, the biosensor may target biologically active analytesrelated to impending or current localized health issues, such as stressproteins (e.g., cytokines) and IL-1α (interleukin 1-alpha) that mayprecede the clinical presentation of skin irritation or inflammation. Inpreferred embodiments, the biosensor functions as a proactive sensor,detecting and signaling the wearer or caretaker of the impendingcondition prior to the presentation of clinical symptoms. This allowstime to administer prophylactic or remedial treatments to the wearerwhich can significantly reduce, if not prevent, the severity andduration of the symptoms. Further, the biosensor 60, by detecting thepresence of a target biological analyte in the wearer's bodily waste(e.g., feces), may detect residual contamination on a surface, such asskin, in contact with the biosensor, and provide and appropriate signal.

[0050] The physico-chemical signal generated by the bio-recognitionelement or elements may be communicated visually to the wearer orcaretaker (i.e., via a color change visible to the human eye). Otherembodiments may produce optical signals, which may require otherinstrumentation to enhance the signal. These include fluorescence,bioluminescence, total internal reflectance resonance, surface plasmonresonance, Raman methods and other laser-based methods. Exemplarysurface plasmon resonance biosensors which may comprise bioconjugatesurfaces as bio-recognition elements are available as IBIS I and IBIS IIfrom XanTec Analysensysteme of Muenster, Germany. Alternatively, thesignal may be processed via an associated transducer which, for example,may produce an electrical signal (e.g., current, potential, inductance,or impedance) that may be displayed (e.g., on a readout such as an LEDor LCD display) or which triggers an audible or tactile (e.g.,vibration) signal or which may trigger an actuator, as described herein.The signal may be qualitative (e.g., indicating the presence of thetarget biological analyte) or quantitative (i.e., a measurement of theamount or concentration of the target biological analyte). In suchembodiments, the transducer may optionally produce an optical, thermalor acoustic signal.

[0051] In any case, the signal may also be durable (i.e., stable andreadable over a length of time typically at least of the same magnitudeas the usage life of the article) or transient (i.e., registering areal-time measurement). Additionally, the signal may be transmitted to aremote indicator site (e.g., via a wire, or transmitter, such as aninfrared or rf transmitter) including other locations within or on thearticle or remote devices. Further, the biosensor 60, or any of itscomponents, may be adapted to detect and/or signal only concentrationsof the target biological analyte above a predefined threshold level(e.g., in cases wherein the target biological analyte is normallypresent in the bodily waste or when the concentration of the analyte isbelow a known “danger” level).

[0052] As described above, the target analytes that the biosensors ofthe present invention are adapted to detect may be pathogenicmicroorganisms such as the pathogenic microorganisms implicated in humangastrointestinal diseases, especially those resulting in diarrhea. Thistype of pathogen is particularly important to monitor due to the numberof children who become seriously ill or die each year from diarrhealdiseases. It has been found that severe chronic diarrhea may result inweight loss and permanent physical and mental developmental retardation.A non-limiting list of pathogenic bacteria that the biosensor 60 maydetect include any of the various pathogenic strains of Escherichia coli(commonly known as E. Coli); Salmonella strains, including S. typhi, S.paratyphi, S. enteriditis, S. typhimurium, and S. heidelberg; Shigellastrains such as Shigella sonnei, Shigella flexneri, Shigella boydii, andShigella dysenteriae; Vibrio cholerae; Mycobacterium tuberculosis;Yersinia enterocolitica; Aeromonas hydrophila; Plesiomonas shigelloides;Campylobacter strains such as C. jejuni and C. coli; Bacteroidesfragilis; and Clostridia strains, including C. septicum, C. perfringens,C. botulinum, and C. difficile. A non-limiting example of a commerciallyavailable biosensor adapted to detect E. coli is available from AndCare,Inc. of Durham, N. C., as test kit #4001. ABTECH, Scientific, Inc., ofYardley, Pa. offers “bioanalytical biotransducers”, available as BBAu-1050.5-FD-X, which may be rendered biospecific (for microorganisms orother target biological analytes as described herein) by covalentlyimmobilizing polypeptides, enzymes, antibodies, or DNA fragments totheir surfaces. Other suitable microbial biosensors are described inU.S. Pat. No. 5,869,272 (gram negative organisms); U.S. Pat. No.5,795,717 (Shigella); U.S. Pat. Nos. 5,830,341; 5,795,453; 5,354,661;5,783,399; 5,840,488; 5,827,651; 5,723,330; and 5,496,700, all of whichare incorporated herein by reference.

[0053] The target analytes that the biosensors of the present inventionare adapted to detect may also be viruses. These may includediarrhea-inducing viruses such as rotavirus, or other viruses such asrhinovirus and human immunodeficiency virus (HIV). An exemplarybiosensor adapted to detect HIV is described in U.S. Pat. Nos. 5,830,341and 5,795,453, referenced above. The disclosure of each of these patentsis incorporated by reference herein.

[0054] In alternative embodiments, the target analytes that thebiosensors of the present invention are adapted to detect may also beparasites, especially those which inhabit the gastrointestinal tractduring some point in their life-cycle. Such parasites may includeprotozoans, worms, and other gastrointestinal parasites. Other examplesof parasites which may be detected include entamoeba histolytica (whichcause amoebic dysentery), trypana cruzi (which causes Chagas disease),and plasmodium falciparum.

[0055] In yet other embodiments, the target analytes the biosensors ofthe present invention are adapted to detect may fungi such as Candidaalbicans. In addition to pathogenic bacteria, certain beneficial colonicbacteria may be detected and/or measured as a health indicator, such asBifidobacteria and Lactobacillus strains.

[0056] The target analytes that the biosensors of the present inventionare adapted to detect may also be proteins or antigens related to skindistress. Preferably, these analytes are detectable on or at the skinsurface, preferably prior to the presentation of clinically observableskin irritation. These may include stress proteins such as cytokines,histamine, and other immune response factors including interleukins(such as IL-1α, IL-2, IL-3, IL-4, and IL-8) and interferons (includinginterferons a and g). Again, these are preferably detectable by thebiosensor 60 prior to the onset of clinically observable redness,irritation, or dermatitis. Additionally, the biosensors of the presentinvention may be adapted to detect enzymes, or other biological factors,implicated in skin irritation (e.g., diaper dermatitis), includingtryspin, chymotrypsin, and lipase.

[0057] The biosensors of the present invention may also comprisebio-recognition systems, including enzymes or binding proteins such asantibodies immobilized onto the surface of physico-chemical transducers.For example, a specific strain of bacteria may be detected viabiosensors employing antibodies raised against that bacterial strain.Alternatively, a target bacteria may be detected by a bio-recognitionelement (including antibodies and synthetic or natural molecularreceptors) specific to extracellular products of the target bacteria,such as toxins produced by that strain (e.g., E. coli). Exemplary enzymeelectrodes that may be used to detect phenols (e.g. in urine or feces)include tyrosinase based electrodes or polyphenol oxidase enzymeelectrodes described in U.S. Pat. No. 5,676,820 entitled “RemoteElectrochemical Sensor,” issued to Joseph Wang et al. on Oct. 14, 1997and U.S. Pat. No. 5,091,299 entitled “An Enzyme Electrode For Use InOrganic Solvents,” issued to Anthony P. F. Turner et al. on Feb. 25,1992, respectively. Both of these patents are incorporated by referenceherein.

[0058] In any of the foregoing examples, the specific microorganism maybe directly detected or may be detected by binding a toxin, enzyme, orother protein produced by the organism or an antibody, such as amonoclonal antibody, specific to the organism. Exemplary biosensorsadapted to detect proteolytic enzymes described in U.S. Pat. No.5,607,567 and toxins in U.S. Pat. Nos. 5,496,452; 5,521,101; and5,567,301.

[0059] The biosensor 60 of the present invention may comprise one ormore “proactive sensors”. This is especially useful in embodiments wherethe detection of the target biologically reactive analyte precedes theonset of clinically observable health symptoms. As used in thisapplication, the term “proactive sensor” refers to a sensor that iscapable of detecting changes or signals on the body of the wearer (i.e.,skin) or in the waste, i.e., inputs, that directly relate or, at aminimum, correlate to the occurrence of an impending or potential healthor skin related even. Proactive sensors may respond to one or morespecific inputs as described above.

[0060] A proactive sensor 60 may detect an impending event or detect aparameter that directly relates, or at a minimum correlates to theoccurrence of an impending event, particularly a systemic or skin healthevent or condition (i.e., the presentation of clinically observableindications or symptoms). An impending event that may be detected orpredicted by a proactive sensor 60 of the present invention may includediarrheal disease, skin irritation or rash (including candidiasis),and/or other types of illness or medical conditions of the wearer suchas a parasitic infestation. The detected biological analyte may be oneor more steps removed from the actual presentation of clinical symptoms.For example, the biosensor may detect potential precursors to the aboveconditions (e.g., fecal contamination of the skin that may precede theelicitation of stress proteins which may, in turn, precede clinicallyobservable skin irritation. A parameter that correlates to an event isany measurable input, signal such as one or more of the potential inputslisted above, that correlates with the occurrence of the event withinthe frame of reference of the system (i.e., a signal caused by the wasteor the wearer). Proactive sensors 60 in an article may measure one ormore different inputs in order to predict an event. For example, theproactive sensor 60 may monitor for Candida albicans in the feces andresidual colonic bacteria on the skin (i.e., detecting residualcontamination) both of which are signals that may precede skinirritation.

[0061] In biosensor embodiments wherein the bio-recognition element doesnot produce an easily visible signal (e.g., a color change), thebiosensor 60 may include a transducer in communication with thebio-recognition element in order to convert the physico chemical signalfrom the bio-recognition element into a usable signal to the wearer,caretaker, or component of the article (e.g., and actuator). Exemplarytransducers may include electrochemical transducers (includingpotentiometric, amperometric, and conductimetric transducers), opticaltransducers (including fluorescence, bioluminescence, total internalreflective resonance, and surface plasmon resonance), thermaltransducers, and acoustic transducers, as known in the art. A powersource, such as a miniature 3 volt watch battery or printed thin filmlithium battery, may be connected with the biosensor 60 to provide anyrequired power.

[0062] The effectiveness of the biosensors of the present invention maybe measured with the Response Factor Test described in the Test Methodsection below. The Response Factor describes the ratio of the responseof the biosensor when exposed to fecal test material compared to theresponse of the biosensor when exposed to physiological saline solutionand is useful in assessing the sensitivity of the biosensor forbiologically active analytes expected to be found preferentially infeces versus urine. The biosensors of the present invention preferablyhave a response factor of at least 2, 3, or 5, more preferably at least10, and even more preferably at least 20 when exposed to fecal testmaterial in aqueous solution or test urine having a concentration of 1gram of fecal test material per 1 gram of physiological saline solution.(Physiological saline solution is used here to represent the backgroundinput signal which is present in most natural environments such asaqueous body fluids.) Such biosensors are able to clearly distinguishbetween the presence of fecal material and the presence of physiologicalsaline solution with respect to a target biologically active analytespecific to feces.

[0063] One way to detect feces is to detect skatole, a substancecommonly found in fecal material. It has been found that the skatoleconcentration in feces is about 180 microgram per gram of fecal materialwhereas the skatole level in urine has been found to be substantiallylower.

[0064] Skatole is generally a product of microbiological degradationthat originates from the catabolism of tryptophane in the intestinalsystem.

[0065] In one preferred embodiment of a skatole detecting biosensor, thebiosensor comprises genetically engineered microorganisms whichassimilate skatole and or other substances. The assimilation of skatolespecific substances can be measured, for example, via the oxygenconsumption during the assimilation process. Microorganisms suitable fordetecting skatole include Acinetobacter baumannii T0136 (FERM P-12891,Japanese patent publication JP05304947), and Bacillus sp T0141 (FREMP-12914, disclosed in Japanese patent publication JP05304948). Suitablebiosensors including such microorganisms are commercially available forexample from Institut für Chemo- und Biosensorik of Münster, Germany,under the designation Mikrobielle Sensoren.

[0066] If microorganisms are incorporated into a biosensor, they may beimmobilized in the biosensor by techniques known in the art such asentrapment, adsorption, crosslinking, encapsulation, covalentattachment, any combination thereof, or the like. Further, theimmobilization can be carried out on many different substrates such asknown the art. In certain preferred embodiments, the immobilizationsubstrate may be selected from the group of polymer based materials,hydrogels, tissues, nonwoven materials, woven materials.

[0067] In certain embodiments, the sensor 60, including any biosensorembodiments, may comprise, be disposed on, or be operatively associatedwith a microchip, such as a silicon chip, MEMs (i.e., microelectromechanical system) device, or an integrated circuit.Microchip-based biosensors may be known as “biochips”. Regardless of thetype of sensor, the microchip may comprise a multiplicity of sensorcomponents having similar or different sensitivities, kinetics, and/ortarget analytes (i.e., markers) in an array adapted to detect differinglevels or combinations of said analyte(s). Further, each sensor in suchan array may provide a different type of signal, including those typesdisclosed herein, and may be associated with different actuators and/orcontrollers. Also, each sensor in an array may operate independently orin association with (e.g., in parallel, combination, or series) anynumber of other sensors in the array.

[0068] The biosensor 60 may be disposed in and/or operatively connectedto any portion of a disposable article that will be exposed to the inputthat the biosensor is designed to detect. For the purposes of thepresent invention, the term “operatively connected” refers to a means ofcommunication such that the biosensor 60 may signal some portion of thearticle 20 when the biosensor 60 detects an input. The biosensor 60 maybe separate from and operatively connected to another portion of thebiosensor 60, another biosensor 60, an actuator, a controller or someother portion or component of the article 20. “Operatively connected”may, for example, include a means of communication such as an electricalconnection via a conductive wire or member, via a transmitted signalsuch as radio frequency, infrared or another transmitted frequencycommunication. Alternatively, the biosensor 60 may be operativelyconnected via a mechanical connection such as a pneumatic or a hydraulicconnection.

[0069] In disposable article embodiments (e.g., diaper 20 of FIG. 1),the biosensor 60 may be located in the front waist region 36, the rearwaist region 38 or the crotch region 37 of article 20, and may beintegral with, disposed adjacent to, joined to, or comprise a portion ofthe chassis 22, the topsheet 24, the backsheet 26, the absorbent core28, side panels 30, leg cuffs 32, a waist feature 34, a fastening system40, the longitudinal 50 or end 52 edges, etc. In certain preferredembodiments wherein the target biological analyte is associated withbodily waste, the biosensor to 60 may be disposed in the crotch regionof the article 20 so as to maximize the probability of the bodily wastecontacting the biosensor 60. In other preferred embodiments wherein thebiosensor is adapted to detect or measure a target biological agent onthe wearer's skin, the biosensor 60 may be disposed on the topsheet,cuff, a waist feature, a feces receiving pocket, spacer, or any otherportion of the article that will contact the wearer's skin during theusage process. In certain embodiments, the biosensor may also beassociated with the lotion or other skin care composition within thearticle.

[0070] The biosensor 60 may be integral with the article 20, or may beinstalled by the caretaker or the wearer. The biosensor during thecourse of wearing the article may also become at least partiallydetached from the article and may be adhered to the wearer's skin. Thebiosensor may be affixed, permanently or detachably (e.g., via amechanical fastening system like Velcro™ or a water soluble adhesive) toa support structure, including adhesive tapes, cellulosic or syntheticwebs, nonwoven highlofts, films, scrims, foams, and the like. Further,the biosensor 60 may be completely contained within the article such asarticle 20 or may have a receiving portion located in the article suchthat it will come into contact with the desired input and anotherportion such as a transmitting portion located either in the article oroutside the article. The biosensor 60 may be external to the article 20yet operatively connected to some portion of the article 20 such thatthe biosensor 60 may detect an input external to the article 20 andprovide a signal to a controller and/or an actuator. In someembodiments, the biosensor may be separate from the article, e.g.,separately applied to some portion of the wearer via adhesive or othermeans as known in the art, and/or may have one or more componentsseparate from the article.

[0071] In some embodiments, a wiping means or element may be provided toallow the wearer or caretaker to clean sufficient bodily waste from thebiosensor 60 to allow a visual assessment or reading of the signal(especially for biosensor embodiments that provide such a signal). Thewiping element may include a web (cellulosic or synthetic), nonwovenhighloft, film, foam, rigid or semi-rigid squeegee like element, and thelike disposed in the article and adapted such that the element may beused to clean the biosensor display. The wiping element may be at leastpartially affixed the to a component of the article, such as a topsheet,in proximity to the biosensor 60 by any known means in the art. Thewiping means may optionally comprise water or any other known cleaningaid to facilitate cleaning of the wearer or the biosensor display.

[0072] In certain preferred embodiments, the article 20 also maycomprise an actuator. As used in this application, the term “actuator”refers to a device that comprises “potential” and a means oftransforming that potential to perform or activate a “responsivefunction.” The potential of the actuator may comprise either stored orpotential energy or stored material. The actuator thus may perform oractivate a responsive function by transforming potential energy tokinetic energy or by releasing or delivering a stored material. A“responsive function” is defined for the purposes of the presentinvention as a function performed upon the bodily waste, the wearer, thearticle, or a component or components thereof, or a signal to the weareror the caretaker. A component of bodily waste may include, for example,moisture, electrolytes, enzymes, volatile gases, bacteria, blood, etc. Acomponent of the wearer may also include skin, genitalia, the anus, theanal sphincter muscle, etc. A component of the article may also includeleg cuffs, waist cuffs or other waste barriers and/or containmentcomponents, side panels, ears, a chassis, an absorbent core, anacquisition component, a fastening system, the longitudinal or endedges, etc. Potential energy may be stored as mechanical, electrical,chemical or thermal energy. “Kinetic energy” as used in this applicationrefers to the capacity to do work or to perform a responsive function asdescribed above (e.g., expansion of a compressed device, rotation of atwisted device, a gel that moves as it changes phases, coating ortreatment of skin or feces, inhibition of an enzyme, adjustment of pH,etc.).

[0073] Triggering the creation of a three dimensional structure tocapture waste, for example, involves responsive functions performed on acomponent of the article and, ultimately, on the waste. Capturing waste,wiping the skin of the wearer or treating the skin with a skin carecomposition, antimicrobial agent, antifungal agent or enzyme inhibitor,for example, are responsive functions performed on the waste and/or thewearer. Adjusting the article's geometry (in one, two or threedimensions) or physical properties (e.g., bending modulus, geometry,etc.) are examples of responsive functions, which may be performed onthe article. Signaling a caretaker and/or the wearer that an event hasoccurred, or is about to occur, is also considered a responsive functionfor the purposes of the present invention. The signal may be visual,auditory, tactile, electrical, chemical, or biological. An actuator of adisposable article may, for example, release or deliver a deodorant,enzyme inhibitor, antimicrobial agent, antifungal agent, skin carecomposition or pH control agent; capture, wipe, cover, trap, immobilize,seal, pump, or store bodily waste; or trigger the release or creation ofa structure or element designed to perform one or more of thesefunctions or any other responsive function upon the waste, wearer,article, or a component thereof.

[0074] The actuator of the present invention may release potentialenergy to perform or activate a responsive function upon the waste, thewearer, the article, or a component thereof. The release of potentialenergy may transform mechanical, electrical, chemical or thermalpotential energy into mechanical, electrical or chemical kinetic energyto perform the responsive function.

[0075] Actuators may be triggered by a threshold level of an input torelease potential energy to perform a responsive function or may respondcontinuously to an input as described below. For example, a compressedfoam has stored compressive mechanical potential energy and may providemechanical kinetic energy when it is released. A twisted foam has storedtorsional mechanical potential energy that may provide mechanicalkinetic energy, i.e., rotation, when it is released. In addition, storedchemical, electrical or thermal energy may be used to releaseelectrical, mechanical, chemical or thermal kinetic energy. The actuatorof a disposable article, for example, may include one or more of thefollowing: stored lotion, anti-fungal or antimicrobial agents, fecesmodification agents, enzyme inhibitors, pH buffers, dyes, pressurizedgas, a compressed foam, a twisted foam, a pump, a closed system liquidtransport member, an electrically sensitive gel, a pH sensitive gel, asalt concentration gel, etc. Potential energy may be stored in anymanner sufficient to maintain or restrain it until it is required.Suitable means for maintaining and/or restraining such energy includebatteries and/or capacitors, elastically, torsionally, compressivelytensioned materials or structures in the form of unreacted reagents, andmaterials capable of performing physical or chemical functions (e.g.,absorbents, emollients, pH buffers, enzyme inhibitors, fecesmodification agents; compressed gases, etc.).

[0076] Alternatively, the actuator of the present invention may comprisea quantity of a stored material that has the capacity to perform oractivate a responsive function upon the waste, the wearer, the article,or any component or components thereof. In one embodiment, for example,the actuator may release or deliver a stored material that performs aresponsive function. In this embodiment, the actuator may be triggeredby a threshold level of an input to discontinuously release or deliverthe stored material at a given time or may release or deliver thematerial continuously. The actuator may, for example, include storedlotion, skin care compositions, antifungal or antimicrobial agents,feces modification agents, enzyme inhibitors, pH buffers, dyes, etc. Incertain preferred embodiments, the material may be delivered by anactuator such as an expanding resilient material, a released highpressure gas, etc.

[0077]FIGS. 2 and 2A illustrate an actuator 90 comprising a compressedresilient material 94, such as a foam, sealed under at least a partialvacuum within a pressure differentiation device 91. A pressuredifferentiation device, as used herein, is any device or structure thatcan maintain a resilient material in a compressed state (e.g., can storeenergy by providing a constraining pressure on the compressed resilientmaterial 94). A “compressed state” is defined as the condition in whicha material is maintained at a smaller volume than the material wouldhave if unconstrained and under zero applied pressure. With respect toresilient materials, a compressed state may generally be achieved byapplying a pressure to a surface of the material or via any other meansknown in the art. The pressure differentiation device may, for example,comprise a vacuum sealed bag or tensioned materials, such as elastic orinelastic bands or strands, strips, films, nonwoven, scrims, or foams,that constrain a resilient material. Preferably, the compression of theresilient material maintained by the pressure differentiation device 91may be at least partially reduced (i.e., the compressed resilientmaterial 94 may at least partially expand) via a trigger mechanism. Atrigger mechanism is any element or device, such as a sensor, actuator,or combination thereof, that responds to an input to effect theequalization of pressure in the pressure differentiation device 91 andallow the compressed resilient material 94 to at least partially expand.Upon release of the compressed material, such as when a targetbiologically active analyte is detected, the compressed resilientmaterial may expand and deliver the stored material. In someembodiments, it may be advantageous for the actuator 90 to comprise avoid space 96.

[0078] The resilient material 94 may comprise any resilient material,including but not limited to, an EVA foam such as the ones availablefrom Foamex Corporation of Eddystone, Pennsylvania identified asSIF/210PPI or Aquazone 80A foam, or from Sentinel Products Corporationof Hyannis, Mass. identified as MC1900 EVA 2 lb/ft³, or a HIPE foam asdescribed in U.S. Pat. No. 5,260,345 entitled “Absorbent Foam MaterialsFor Aqueous Body Fluids and Absorbent Articles Containing SuchMaterials” issued to DesMarais et al. on Nov. 9, 1993; U.S. Pat. No.5,387,207 entitled “Thin-Until-Wet Absorbent Foam Materials For AqueousBody Fluids And Process For Making Same” issued to Dyer et al. on Feb.7, 1995; and U.S. Pat. No. 5,625,222 entitled “Absorbent Foam MaterialsFor Aqueous Fluids Made From high Internal Phase Emulsions Having VeryHigh Water-To-Oil Ratios” issued to DesMarais et al. on Jul. 22, 1997.(Each of the patents identified above is incorporated by referenceherein.)

[0079] In some embodiments of the present invention, the pressuredifferentiation device 91 may comprise a bag, such as soluble bag 92.The soluble bag 92 may be soluble in the presence of one or moredifferent types of input, such as water, urine, fecal enzymes, a pHlevel, etc., and may have physical and/or chemical characteristics(e.g., thickness) that may be designed to set a threshold level of thatinput required to dissolve the bag. The soluble bag may, for example,comprise a plastic film that is soluble to water such as PVA filmssupplied by Chris-Craft Industrial Products, Inc. of South Holland, Ill.as MONOSOL M7031, M7030, M8630, M8534, or E6030 film, or H. B. FullerCompany of St. Paul, Minn. as HL 1636 or HL 1669-X. The film thickness,for example, may also be modified to provide a desired activation. Thefilm used may, for example, also have a thickness in the range fromabout 0.0005 to about 0.0015 inches. An HL 1636 film having a thicknessof about 0.001 inches, for example, will activate with a moisturecontent of about 0.049 grams per square inch.

[0080] The actuator may alternatively comprise an electrically sensitivegel. Electrically sensitive gels are polymeric gel networks that, whenat least partially swollen with water, change volume and/or geometryunder the application of an electric current or field. For example,certain partially ionized polyacrylamide gels will undergo anisotropiccontraction of about 50% under weak electric fields (e.g., 0.5 volts/cm)when immersed in acetone and water. Alternative electrically sensitivegels may undergo electrically induced bending in the presence of waterand a surfactant or may undergo an oscillating wave motion whensubjected to an oscillating electric field. It is believed that localshrinkage may be induced in a portion of the gel, e.g., one side of agel element, by concentrating positively charged surfactant molecules onthe negatively charged gel polymer in an electric field. Changing theintensity and/or the polarity of the field induces a movement in the gelas one side decreases in length (e.g., a gel formed in a strip maycurl). Electrically sensitive gels may comprise variable geometries suchas rectangular, circular, reticulated grid, etc. patterns in order toprovide a valve to release a material, allow a bodily waste to flowthrough, prevent a bodily waste from flowing through, encapsulate abodily waste, etc. as they change volume and/or geometry. Anelectrically sensitive gel formed in a strip, for example, may be bentto provide an available void space for when electrical activity in theexternal anal sphincter muscle predictive of defecation or urination isdetected.

[0081] In FIGS. 5A and 5B, for example, a strip of electricallysensitive gel 494 is shown in a circuit in which fecal moisture maybridge the contacts 485 and allow current to flow to the electricallysensitive gel either bending or straightening the strip. Alternatively,an electrically sensitive gel 594 formed in a reticulated grid pattern595, such as shown in FIGS. 6A, 6B and 6C, may be electrically inducedto swell or shrink when an imminent urination is detected to form avalve that allows and/or prevents urine flow to another portion of thearticle 20. FIG. 6A, for example, shows a circuit including areticulated grid pattern of an electrically sensitive gel. FIGS. 6B and6C further show a microscopic view of the grid in a shrunk and in aswelled configuration, respectively. An exemplary material is a weaklycross-linked PAMPs gel (poly(acrylamido-2-methyl propane) sulphonicacid). This type of gel may perform various functions such as applyingor delivering a chemical feces treatment agent. Other exemplaryelectrically sensitive gels are described in U.S. Pat. No. 5,100,933issued to Tanaka on Mar. 31, 1990 and WO 9202005, both of which areincorporated by reference herein. Alternatively, pH sensitive gels orsalt concentration sensitive gels that change volume and/or geometry atspecific pH or salt concentrations, respectively, may be used as anactuator of the present invention.

[0082] The actuator may be disposed in and/or operatively connected toany portion of disposable article that will allow the actuator toperform a responsive function upon the bodily waste, the wearer, thearticle, or a component thereof. In article 20, for example, theactuator may be located in the front waist region 36, the rear waistregion 38 or the crotch region 37 of article 20, and may be integralwith, disposed adjacent to or joined to a component of the chassis 22,the topsheet 24, the backsheet 26, the absorbent core 28, side panels30, leg cuffs 32, a waist feature 34, a fastening system 40, thelongitudinal 50 or end 52 edges, etc. The actuator may also becompletely contained within the article such as article 20, may have aportion located in the article and a portion located outside the article20, or may be completely external to the article 20. An actuator or aportion of an actuator may be operatively connected to one or morebiosensors 60, one or more controllers 80, another portion of theactuator or another portion of the article 20. Further, the actuator maybe integral with the article 20, or may be installed by the caretaker orthe wearer.

[0083] The article 20 may also include a controller. A “controller” isdefined for the purposes of this application as a device that receivesan input from a biosensor and determines if one or more actions are tobe taken. The controller may receive a signal from the biosensor 60 anddirect the actuator to perform a responsive function upon the bodilywaste, the wearer, the article or a component thereof. Alternatively,the actuator may receive the signal directly from the biosensor 60 andperform a responsive function upon the wearer, the waste, the article ora component thereof. The controller may include materials that undergochemical or physical change, may be a chemical, mechanical or electricaldevice that processes information from a biosensor, etc. The controllermay include a transducer comprising a polylayer Langmuir-Blodgett film,wherein one or more layers includes a bio-recognition element. Uponcontact with water, Langmuir-Blodgett films are known to spontaneouslyreorganize, resulting in regions with more layers than the original filmand other regions having fewer layers. This reorganization may exposethe bio-recognition element to the environment preferentially in thepresence of water, such as in bodily waste, which may contain the targetbiological analyte. Thus, the number of false positives can be reducedand the shelf-life of the biosensor can be extended. Alternatively, anelectrical controller that receives signals such as electrical potentialfrom an electrochemical biosensor may receive and monitor multipleelectrical signals and may repeatedly trigger the actuator. Thecontroller may be integral with the biosensor component, integral withthe actuator component, or a separate component of the system.

[0084] The controller may be disposed in and/or operatively connected toany portion of a disposable article that will allow the controller toreceive a signal from the biosensor 60 and to provide a signal to theactuator. In article 20, for example, the controller may be located inthe front waist region 36, the rear waist region 38 or the crotch region37 of article 20, and may be integral with, disposed adjacent to orjoined to the chassis 22, or a component of the topsheet 24, thebacksheet 26, the absorbent core 28, side panels 30, leg cuffs 32, awaist feature 34, a fastening system 40, the longitudinal 50 or end 52edges, etc. The controller may be integral with the article 20, or maybe installed by the caretaker or the wearer. The controller may becompletely contained within the article such as article 20, may have aportion located in the article and a portion located outside thearticle, or may be located completely outside the article 20. Thecontroller or a portion of a controller may be operatively connected toone or more biosensors 60, one or more actuators 90, another portion ofthe controller or another portion of the article 20. The controller, forexample, may receive a signal from the biosensor 60 and provide a signalto the actuator, e.g., by a radio frequency (rf) transmission.

[0085] Although distinct structural elements may perform the biosensor60, actuator and controller functions, the biosensor 60, actuator and/orcontroller functions of the present invention need not be performed bydistinct structural elements. The biosensor 60 and controller functions,for example, may be performed by the same structural element.

[0086] A “responsive system” is defined for the purposes of thisapplication as a system that includes a biosensor 60 and an actuatorthat acts upon the bodily waste, the wearer, the article, or a componentor components thereof when the biosensor 60 detects the appropriatetriggering input. Upon sensing a given input parameter, the actuatoraffects the release of stored energy or the release or delivery ofstored material to perform a responsive function. For example, when aproactive biosensor 60 including a transducer detects an impendingevent, the transducer provides a signal to the actuator affecting therelease of stored energy. By detecting an input signal prior to theimpending event, a responsive system in the article may be triggered toprepare for the event or to signal the caregiver or the wearer of theimpending event. This allows construction of articles in which thewaste-management or treating technology is initially “hidden” orunobtrusive, but which is available at, or just before, the moment ofneed and/or in which the article may provide the caregiver or the wearerthe opportunity to prepare for an event in advance (e.g., administer aprohylactic treatment to the wearer in the event of detected pathogenicmicroorganisms or residual fecal contamination). Regardless of thespecific input, the biosensor 60 in these embodiments may trigger anactuator to perform an action on the article, the wearer or theenvironment to prepare for the occurrence of the event or provide asignal to the caregiver that the impending event is about to occur. Ifthe biosensor 60 comprises a sensing system, one actuator may betriggered by different biosensors and/or signals, or different actuatorsmay be triggered by different biosensors and/or signals. Alternatively,one biosensor and/or signal may trigger multiple actuators.

[0087] A responsive system may respond in either a “continuous” or a“discontinuous” manner. As used in this application, a “continuousresponsive system” refers to a responsive system in which the output isquantitatively dependent upon the quantity of the input, i.e.,continuously increasing quantities of the input are required to affectcontinuously increasing quantities of the output, or where the output ofthe responsive system comprises a passive release of a stored material.A super absorbent polymer placed in an absorbent core of an article, forexample, provides a continuous response in which the output isquantitatively dependent upon the quantity of the input, i.e., asincreasing quantities of liquid waste contact the super absorbentpolymer, an increasing amount of the polymer contains that liquid untilthe capacity of the polymer is exhausted. A stoichiometric chemicalreaction is another example of a system having a continuous response toincreasing output. In the reaction A+excess B→C, for example, the amountof excess B converted to C is stoichiometrically and, therefore“continuously,” related to the amount of A available in the system.

[0088] A “discontinuous responsive system” of the present invention,however, refers to a responsive system that has an output function thatis essentially independent of the quantity of the input beyond athreshold level. For example, when one or more threshold levels of agiven input are met, the responsive system may release all or apre-designated portion of its stored energy or deliver, i.e., activelytransport, all or a pre-designated portion of its stored material toperform a specific responsive function. In an ideal embodiment of thepresent invention, the output function, f(x), includes a “step” functionas shown in FIG. 3A. In this embodiment, the rate of change in theoutput with increasing levels of input (d(output)/d(input)), i.e., theslope or first derivative f′(x) of the output function f(x), ispreferably essentially zero when the amount of input is above or belowthe threshold level. At the threshold level, however, thed(output)/d(input) rate of change preferably approaches infinity. Thus,in the ideal discontinuous response, the limit of the function f(x−ε) asε→0 is not equal to the limit of the function f(x+ε) as ε→0, i.e.,${\underset{ɛ\rightarrow 0}{\lim \quad}\quad {f\left( {x - ɛ} \right)}} \neq {\lim\limits_{ɛ\rightarrow 0}{{f\left( {x + ɛ} \right)}.}}$

[0089] The present invention, however, recognizes that in the physicalworld an ideal instantaneous step change at the threshold level is notnecessary and may not even be possible in many instances. In a preferredembodiment, it is only necessary that the output function have a virtualstep change with very little change in the input at or around thethreshold level of the input. Thus, the present invention contemplates adiscontinuous responsive system of the present invention having anoutput function that responds in a sufficiently discontinuous manner inthe transition region such that the output function has at least aminimum relative degree of steepness in the transition region. While notwishing to be limited to a particular method of describing or modeling adiscontinuous system, in a preferred method of determining whether agiven output function performs in a sufficiently discontinuous manner asdefined for the purposes of the present invention, the slope of theoutput curve at the inflection point is compared with the relative slopeof a line between the first and last points of the transition region.For example, FIG. 4A shows a graph of an exemplary output function, f(x)along with aligned graphs of the first, f′(x), and second, f″(x), andthird, f′″(x), derivatives of the exemplary output function. The outputfunction f(x) describes the effect of the in put (x or I) on the outputor response (R(I)). For purposes of the present invention, thetransition region is defined as the region between the relative maxima,R(I₁), and the minima, R(I₂), of the second derivative, f″(x), of theoutput function, f(x). The relative maxima, R(I₁), and the relativeminima, R(I₂), are points at which the third derivative, f′″(x), equalszero. The inflection point, I₀, is defined as the point in thetransition region at which the second derivative, f″(x), equals zero,i.e., ${\frac{^{2}R}{I^{2}}\begin{matrix} \\ \\\end{matrix}\begin{matrix}\quad \\\quad \\{I = I_{0}}\end{matrix}} = 0.$

[0090] The comparison of the slope of the output function at theinflection point to the slope of a line between the first and the lastpoints of the transition region can be described by the equation:${\frac{R}{I}\begin{matrix}{\quad} \\{\quad} \\{{I} = I_{0}}\end{matrix}} = {k{\frac{\left( {\Delta \quad R_{T}} \right)}{\left( {\Delta \quad I_{T}} \right)}.}}$

[0091] In this equation dR/dI at the inflection point is the firstderivative of the output function at that point. The term ΔI_(T) is thechange in the input to the responsive system between the first, I₁, andlast, I₂, points of the transition region, i.e., I₂-I₁, and the termΔR_(T) is the change in the response of the output function between thefirst and last points of the transition region, i.e., R(I₂)-R(I₁). Thecoefficient k is a proportional constant that describes the relativesteepness of the slope of the output function at the inflection point,I₀, compared to the slope of a line between the first and last points ofthe transition region. In order that the responsive system have adiscontinuous output function, the proportional constant k must be atleast about 2.0, preferably at least about 3.0, more preferably at leastabout 5.0, even more preferably at least about 10.0, with at least about100.0 being the most preferred.

[0092] In certain embodiments, the relative degree of steepness in thetransition region of a discontinuous responsive system may also bemodeled by a transfer function of a control system having a series of aninteger number, n, first order lags with an equal time constant. Thetransfer function of the responsive system is defined for the purposesof the present invention as the ratio of the Laplace transforms of theoutput (responding variable) to the input (disturbing variable). See,e.g., Robert H. Perry & Don Green, Perry's Chemical Engineers' Handbook,Sixth Ed., Chap. 22 (McGraw Hill, Inc. 1984). As shown in FIG. 4B, therelative degree of steepness of an output function may be approximatedby the formula: KG(s)=K/Ts+1)^(n) in which KG(s) is the transferfunction, K is a proportional element, T is the time constant of thesystem, and n is the integer number of first order time lags. In thismodel, as the number n increases, the steepness of the output functionin the transition region increases, and the model begins to approximatea discontinuous responsive system. Certain discontinuous responsivesystems of the present invention preferably may be modeled by the aboveformula when n is greater than or equal to about 25, with n beinggreater than or equal to about 50 being more preferred, and n beinggreater than or equal to about 100 being the most preferred.

[0093] As shown in FIG. 3A, a responsive system of the present inventionmay include a single threshold level at which the responsive system mayrelease all of its stored energy to perform a specific responsivefunction or may include multiple threshold levels at which the systemmay release a pre-designated portion of its stored energy to perform oneor more specific responsive functions at each of the threshold levels.In an embodiment having a single threshold level, for example, theresponsive system may release all of its stored energy to perform theentire responsive function when that threshold level is met. In such asingle threshold embodiment, In this example, the discontinuousresponsive system includes a system that has two states such as on oroff. When a threshold quantity of an input such as a target biologicalmaterial is present in the absorbent article, the responsive system mayperform a single responsive function upon the waste, the wearer, thearticle or a component thereof, such as enveloping the waste away fromthe skin of the user or providing an easily detectable visual signal tothe wearer or caregiver. Thus, the discontinuous responsive system mayperform a one-time “switch-like” function that changes from one state toanother in the presence of a threshold level of an input.

[0094] Alternatively, as shown in FIG. 3B, the responsive system mayhave multiple threshold levels at which when each threshold level is metthe system may release a given “quanta” of energy or deliver a givenquantity of material to perform a specific responsive function. In thisembodiment, when each threshold level is met, a portion of the entireresponsive function may be performed and/or different independentresponsive functions may be performed in response to different thresholdlevels being met. For example, a responsive system may monitor a fecalenzyme and when each threshold enzyme level is met may deliver an equalor unequal quantity of enzyme inhibitor(s) or lotion, or deliver a pHbuffer at the first threshold level and perform another responsivefunction such as delivering a quantity of enzyme inhibitor(s) at thesecond threshold level. In each transition region, the responsive systemresponds essentially the same as the transition region in the singlethreshold embodiment described above.

[0095] In addition, a responsive system may monitor multiple inputs suchas one or more pathogenic bacteria and/or one or more fecal enzymes andperform one or more responsive functions when the threshold levels ofthe different inputs are met or may perform one responsive function onlywhen two or more of the threshold levels of the different inputs aremet. Thus, a controller may monitor multiple different inputs andperform a different responsive function when the threshold level of thedifferent inputs are met. Alternatively, the controller may perform alogic OR-gate type function such that a responsive function may beperformed when one or more threshold levels of the multiple inputs aremet. The controller may also perform a logic AND-gate type function suchthat a responsive function may be performed when each threshold level oftwo or more different inputs is met.

[0096] The responsive system may also comprise a “closed loop” or an“open loop” system. A “closed loop” system, which is also referred to asa “feedback control loop” system, includes distinct biosensor 60 andactuator components and performs a responsive function upon the input.In some preferred embodiments, the system may also use a detection or ameasurement of an element or a parameter of the output condition as atleast one trigger of the responsive function that is performed upon theinput. The output condition may be the state of the input conditionafter the actuator has had the opportunity to perform a responsivefunction on the input condition. The responsive function may beperformed when the output condition reaches a threshold level, or may beperformed only when the output condition and one or more otherconditions are met. Acting upon the input may include acting upon theelement sensed, e.g., sensing a microorganism and acting upon themicroorganism, or may include acting upon a composition of which theelement sensed is an integral component, e.g., sensing a fecal bacteriaand acting upon the fecal mass or residual feces on the wearer's skin Asdescribed above, a feedback control loop system includes at least twodistinct components: the biosensor 60 and the actuator. The biosensor 60detects an event, or a parameter associated with that event. Theactuator receives a signal and performs a responsive function on theinput condition detected by the biosensor 60. The feedback control loopmay further include a controller. In this case, the biosensor 60 mayprovide a signal to the controller, and the controller may direct theactuator to perform a responsive function upon the input condition. Thecontroller may be a separate component of the responsive system or thecontroller function may be performed by the biosensor 60 and/or theactuator.

[0097] The feedback control loop may be “non-modulating” or“modulating.” In a “non-modulating” feedback control loop responsivesystem the responsive system acts as a one-time switch in which theactuator performs a responsive function on the input when the thresholdlevel of the output condition is met. For example, the biosensor 60 maydetect the presence of or measure the concentration of a specificpathogenic microorganism, and the actuator may signal the caretaker of apotential incipient infection. In this example, the actuator acts uponthe input detected by the biosensor 60. A “modulating” feedback controlloop, however, includes a biosensor 60, an actuator and a controller. Ina modulating feedback control loop, the output condition is monitoredconstantly or repeatedly, and the controller directs the actuator toperform a responsive function on the input in order to maintain theoutput condition at a desired set point or within a desired range or toprovide a continuous measurement of the level or concentration of thetarget biological analyte.

[0098] An “open loop” system, however, is a system that responds to theinput to perform a responsive function without using feedback, i.e., theoutput has no effect upon the sensed input entering the system. An openloop system may include a responsive system that has a single devicethat performs the functions of both the biosensor 60 and the actuator ormay have distinct biosensor 60 and actuator components in which theactuator acts upon something other than the input. A super absorbentpolymer placed in an absorbent core of a disposable absorbent article,for example, provides an open loop response because the polymer onlyincludes a single device that performs the functions of the biosensor 60and actuator. Alternatively, an open loop responsive system may includea biosensor 60 that detects bodily waste or a component of that bodilywaste, and an actuator that performs a responsive function in acontinuous or a discontinuous manner on something other than the inputdetected by the biosensor 60.

[0099] The present invention includes responsive systems that provide adiscontinuous or continuous response, whether open loop or closed loop.Other responsive systems are described in U.S. patent application Ser.Nos. 09/106,424 entitled “Disposable Article Having A DiscontinuousResponsive System” filed on Jun. 29, 1998 (P&G Case Number 7197); Ser.No. 09/107,563 entitled “Disposable Article Having A Responsive SystemIncluding A Feedback Control Loop” filed on Jun. 29, 1998 (P&G CaseNumber 7198); and Ser. No. 09/106,225 entitled “Disposable ArticleHaving A Responsive System Including A Mechanical Actuator” filed onJun. 29, 1998 (P&G Case Number 7199), each of which is incorporatedherein by reference.

[0100] An example of a diaper 20 of the present invention may include aresponsive system that includes a biosensor 60 as shown in FIG. 1 and anactuator as shown in FIG. 2. In this embodiment, the biosensor 60 maycomprise a transducer operatively associated with a bio-recognitionelement adapted to detect E. coli in feces. Upon the specific detectionof a threshold level of E. coli by the bio-recognition element, thetransducer signals the actuator with an electrical current. The articleshown in FIG. 1 may include an actuator that comprises a compressedresilient material 94 vacuum sealed under a water soluble film 91, asshown in FIG. 2 (e.g., a PVA film). Upon receipt of the proper signalfrom the biosensor 60, the actuator may close a switch, for example mayrelease a small amount of stored water to contact and dissolve the watersoluble film 91. This results in the release of the stored mechanicalenergy in the compressed foam. The resilient material 94 expands andforms a spacer to provide void volume for the incipient feces.Alternatively, the switch closure may additionally release anantimicrobial to control the E. coli and/or a visible dye to signal theE. coli presence to the wearer or caretaker. In another embodiment, theresponsive system may include an actuator that alerts the caretaker orthe wearer of an impending event such as a diarrheal infection or a skinirritation (e.g., candidiasis).

Test Method

[0101] Response Factor Test:

[0102] With the Response Factor Test as described hereafter, theresponse of a quantitative sensor as a reaction to exposure to aspecific substance or composition can be measured.

[0103] The specific substances or compositions for which this test issuitable include: fecal test material in aqueous solution having aconcentration of 1 gram of fecal test material per 1 gram ofphysiological saline solution; fecal test material in test urinesolution having a concentration of 1 gram of fecal material per 1 gramof test urine solution; test urine solution; a solution of skatole inphysiological saline solution having a concentration of 180 microgramsof skatole per gram of physiological saline solution; physiologicalsaline solution.

[0104] All measurements are carried at body temperature (37° Celsius).The method includes the following steps in the following order:

[0105] 1) Record quantitative response of the sensor after exposure tophysiological saline solution for 24 hours. The background response isthe maximum recorded response.

[0106] 2) Expose the sensor to specified substance or composition.

[0107] 3) Record quantitative response of the sensor while sensor isstill exposed to the specified substance or composition for 24 hours.Substance response is the maximum recorded response.

[0108] The Response Factor is obtained by normalizing the substanceresponse with the background response. In case the Response Factor issmaller than 1, the reciprocal value of the Response Factor is reportedas the Response Factor (i.e., the response may be inversely correlatedwith the input).

[0109] While particular embodiments and/or individual features of thepresent invention have been illustrated and described, it would beobvious to those skilled in the art that various other changes andmodifications can be made without departing from the spirit and scope ofthe invention. For example, although the present invention isillustrated and described primarily with respect to a disposable diaper,the present invention is not limited to this embodiment. The presentinvention may also be used, for example, in articles that are applieddirectly to a wearer (e.g., to the perianal or perineal regions of thewearer) prior to the application of a disposable diaper or in place of adisposable diaper, in a pull-on diaper, a diaper insert, a sanitarynapkin, a tampon, etc. Further, it should be apparent that allcombinations of such embodiments and features are possible and canresult in preferred executions of the invention. Therefore, the appendedclaims are intended to cover all such changes and modifications that arewithin the scope of this invention.

What is claimed is:
 1. A disposable article to be fitted to a wearercomprising: a biosensor including at least one bio-recognition element,the biosensor being adapted to detect a target biological analyte inbodily waste or on the wearer's skin.
 2. The disposable article of claim1 wherein the bio-recognition element comprises a biologically reactiveagent.
 3. The disposable article of claim 1 wherein the biosensor isselected from the group of: a biocatalytic biosensor and a bioaffinitybiosensor.
 4. The disposable article of claim 3 wherein the bioaffinitybiosensor is selected from the group of: a chemoreceptor-based biosensorand an immunosensor.
 5. The disposable article of claim 1 wherein thebio-recognition element is selected from the list including: an enzymeor sequence of enzymes; an antibody; DNA; an organelle; a membranereceptor protein; a natural or synthetic cell membrane; viable ornonviable bacterial, plant, or animal cells; at least a portion of anerve bundle; at least a portion of a sensing organ.
 6. The disposableabsorbent article of claim 5 wherein the bio-recognition element isselected from the group including Acinetobacter baumannii TOI36 andBacillus sp TOI41.
 7. The disposable absorbent article of claim 6wherein the bio-recognition element is disposed on a substrate selectedfrom the group of: polymer based materials, hydrogels, tissues, nonwovenmaterials, and woven materials.
 8. The disposable article of claim 1wherein the biosensor detects target biological analytes selected fromthe following group: pathogenic bacteria, colonic bacteria, viruses,parasites, bacterial toxins, fungi, enzymes.
 9. The disposable articleof claim 5 wherein the pathogenic bacteria selected from the list:Escherichia coli; Salmonella typhi; Salmonella paratyphi; Salmonellaenteriditis; Salmonella typhimurium; and Salmonella heidelberg; Shigellasonnei; Shigella flexneri; Shigella boydii; Shigella dysenteriae; Vibriocholerae; Mycobacterium tuberculosis; Yersinia enterocolitica; Aeromonashydrophila; Plesiomonas shigelloides; Campylobacter jejuni;Campylobacter coli; Bacteroides fragilis; Clostridia septicum,Clostridia perfringens, Clostridia botulinum, and Clostridia difficile.10. The disposable article of claim 1 wherein the biosensor detects thetarget biological analyte associated with a systemic or skin healthcondition in the wearer prior to the onset of clinically observablesymptoms of the condition.
 11. The disposable article of claim 1 whereinthe biosensor detects the target biological analyte only above apre-defined threshold level.
 12. The disposable article of claim 1wherein the biosensor additionally comprises a transducer.
 13. Thedisposable article of claim 12 wherein the transducer is selected fromthe group including electrochemical, optical, thermal, and acoustictransducers.
 14. The disposable article of claim 12 wherein thetransducer signals only when target biological analyte is above apre-defined threshold level.
 15. The disposable article of claim 1wherein the biosensor provides a signal to at least one of the group of:the wearer, a caretaker, an actuator.
 16. The disposable article ofclaim 15 wherein the signal is a visible indication.
 17. The disposablearticle of claim 15 wherein the signal is qualitative.
 18. Thedisposable article of claim 15 wherein the signal is quantitative. 19.The disposable article of claim 15 wherein the signal is durablethroughout at least the usage life of the article.
 20. The disposablearticle of claim 1 wherein the article additionally comprises a cleaningelement for the biosensor.
 21. The disposable article of claim 1 whereinthe biosensor is affixed to a support element.
 22. The disposablearticle of claim 1 wherein the support element adheres to the wearer'sskin.
 23. The disposable article of claim 21 wherein the support elementis an adhesive tape.
 24. The disposable article of claim 1 wherein thebiosensor is detachable from the article.
 25. The disposable article ofclaim 1 wherein the biosensor adheres to the wearer's skin.
 26. Thedisposable article of claim 1 wherein the bodily waste is feces, urineor menses.
 27. The disposable article of claim 1 wherein the bodilywaste is residual fecal contamination located on the wearer's skin. 28.The disposable article of claim 1 further comprising an actuator thatperforms a responsive function when the biosensor detects a targetbiological analyte.
 29. The disposable article of claim 28 wherein theresponsive function is a signal to a caretaker, or the wearer.
 30. Thedisposable article of claim 28 wherein the actuator transforms apotential energy to perform the responsive function, the potentialenergy being one or more selected from the group of: mechanical energy,electrical energy and chemical energy.
 31. The disposable article ofclaim 28 wherein the responsive function is one or more selected fromthe group of: creating a void volume, treating skin, creating a foamingsystem and signaling a caregiver.
 32. The disposable article of claim 1further comprising a receiver.
 33. The disposable article of claim 32wherein the receiver is integral with said article.
 34. The disposablearticle of claim 32 further comprising a transmitter.
 35. The disposablearticle of claim 34 wherein the transmitter comprises an infraredtelemetry transmitter.
 36. The disposable article of claim 1 wherein thebiosensor has a Response Factor of at least 5 when exposed to feces. 37.The disposable article of claim 1 wherein the biosensor has a ResponseFactor of at least 10 when exposed to feces.
 38. The disposable articleof claim 1 wherein the biosensor has a Response Factor of at least 20when exposed to feces.
 39. The disposable absorbent article of claim 1wherein the biosensor has a Response Factor of at least 5 when exposedto a solution of skatole in physiological saline solution having aconcentration of 180 micrograms of skatole per gram of physiologicalsaline solution.
 40. A disposable absorbent article to be fitted to awearer comprising: a topsheet; a backsheet joined with the topsheet; anabsorbent core disposed between the topsheet and the backsheet; and abiosensor disposed on the disposable article, the biosensor including atleast one bio-recognition element wherein the biosensor is adapted todetect a target biological analyte in bodily waste.
 41. The disposableabsorbent article of claim 40 wherein the disposable article is chosenfrom the following group: a sanitary napkin, a diaper, a training pantand an adult incontinence device.
 42. The disposable absorbent articleof claim 40 wherein the bio-recognition element comprises a biologicallyreactive agent.
 43. The disposable absorbent article of claim 40 whereinthe biosensor is selected from the group of: a biocatalytic biosensorand a bioaffinity biosensor.
 44. The disposable absorbent article ofclaim 43 wherein the bioaffinity biosensor is selected from the groupof: a chemoreceptor-based biosensor and an immunosensor.
 45. Thedisposable absorbent article of claim 40 wherein the bio-recognitionelement is selected from the list including: an enzyme or sequence ofenzymes; an antibody; DNA; an organelle; a membrane receptor protein; anatural or synthetic cell membrane; viable or nonviable bacterial,plant, or animal cells; at least a portion of a nerve bundle; at least aportion of a sensing organ.
 46. The disposable absorbent article ofclaim 40 wherein the biosensor detects target biological analytesselected from the following group: pathogenic bacteria, colonicbacteria, viruses, parasites, bacterial toxins, fungi, enzymes.
 47. Thedisposable absorbent article of claim 46 wherein the pathogenic bacteriaselected from the list: Escherichia coli; Salmonella typhi; Salmonellaparatyphi; Salmonella enteriditis; Salmonella typhimurium; andSalmonella heidelberg; Shigella sonnei; Shigellaflexneri; Shigellaboydii; Shigella dysenteriae; Vibrio cholerae; Mycobacteriumtuberculosis; Yersinia enterocolitica; Aeromonas hydrophila; Plesiomonasshigelloides; Campylobacter jejuni; Campylobacter coli; Bacteroidesfragilis; Clostridia septicum, Clostridia perfringens, Clostridiabotulinum, and Clostridia difficile.
 48. The disposable absorbentarticle of claim 40 wherein the biosensor adheres to the wearer's skin.49. The disposable absorbent article of claim 40 wherein the biosensorhas a Response Factor of at least 5 when exposed to feces.
 50. Thedisposable absorbent article of claim 40 wherein the biosensor has aResponse Factor of at least 10 when exposed to feces.
 51. The disposableabsorbent article of claim 40 wherein the biosensor has a ResponseFactor of at least 20 when exposed to feces.
 52. The disposableabsorbent article of claim 40 wherein the biosensor has a ResponseFactor of at least 5 when exposed to a solution of skatole inphysiological saline solution having a concentration of 180 microgramsof skatole per gram of physiological saline solution.